TrimSpa X32 has launched onto the dietary
supplement and weight loss markets with a deluge of promotion, from
a celebrity endorser to a million dollar contest, from sponsorship
of award shows to a website filled with information, testimonials,
and a personal consultation tool. But is the product safe and are
the advertisements for the product truthful and nonmisleading? This
paper examines TrimSpa X32 to determine whether it complies with
the applicable regulatory guidelines of both the United States Food
and Drug Administration (FDA) and United States Federal Trade
Commission (FTC). In order to do so, this paper first analyses the
Dietary Health and Supplement Act of 1994 which provides the basis
for FDA regulations and “Dietary Supplements: An Advertising
Guide for Industry” which sets out guidelines to aid the FTC
in regulating the advertising of dietary supplements and also
provides a comprehensive guide to advertisers to aid them in
complying with FTC regulations. This paper concludes that TrimSpa
currently complies with all applicable regulations. However, there
are several issues which may arise in the future, including safety
and efficacy concerns and potential claims of misleading
advertisements and duty-to-warn litigation.

INTRODUCTION

Americans are fat and have consistently become
fatter over the past twenty years.[1] However, consumers’ realization of the
health risks of obesity and societal pressure for slimmer bodies
has generated a new problem: an obsession with weight loss. This
obsession has launched a fifty billion dollar weight loss
industry.[2] Americans have been bombarded with new diet plans,
diet foods, and diet drugs. While many debate the merits of Weight
Watchers, Jenny Craig, the South Beach Diet, and the Atkins Diet,
it appears that Americans have embraced these tools as means to the
same end: weight loss. But, is the fast-food culture willing to
accept long-term solutions requiring exercise, portion control, and
nutritionally balanced meals? Perhaps Americans do not have the
time for such measures or, just as they prefer a quick meal on the
go, they prefer a quick fix. In the spirit of the free market,
businesses have attempted to sate America’s love of quick,
easy solutions with the introduction of weight loss drugs.

One quick and easy solution arrived in the form of
“fen-phen”. Unfortunately, fen-phen, a combination of
two different drugs, fenfluaramine and phentermine, caused the
deaths of several users.[3] Nevertheless, even after the fen-phen disaster rode
the front pages of newspapers across the country, American dieters
wanted the “next best thing” and sought out weight loss
alternatives, including herbal fen-phen substitutes and other
herbal remedies. Such remedies often include ephedrine/ephedra
(which has since been taken off the market), St. Johns Wort, and
other herbal ingredients.[4] One such remedy, TrimSpa X32, has now hit the market
with a big splash – endorsed by a celebrity and backed by a
“Million Dollar Makeover Challenge” to
customers.[5] For a mere $39.95 per bottle[6] , consumers can shed pounds quickly and be
overweight no more. Television commercials for TrimSpa X32 feature
a newly svelte Anna Nicole Smith proclaiming the benefits of this
new herbal weight loss remedy and its website declares that TrimSpa
X32 is #1 in Hoodia gordonii. But, is this truly the answer to the
United States’ growing obesity problem? Do consumers even
know what Hoodia gordonii is? The question remains as to whether
this product is safe and whether is should be allowed on the
market. This paper examines the basis for FDA and FTC regulation of
herbal remedies and explores whether TrimSpa X32 is in compliance
with the applicable regulations, and finally whether it should
remain on the market.

REGULATION OF HERBAL AND DIETARY
SUPPLEMENTS

I. Food and Drug Administration

Approximately twenty-five years ago, Congress
debated the nature and strength of regulations necessary for the
$15 billion a year herbal and dietary supplement industry.[7] Enormous grassroots and lobbyist pressure encouraged
Congress to create a new FDA-regulated category for supplements,
separate from both drugs and food. The new statute, Dietary
Supplement Health and Education Act of 1994 (DSHEA), was the result
of Congress’ findings that “dietary supplements are
safe within a broad range of intake, and safety problems with the
supplements are relatively rare” and “legislative
action that protects the right of access of consumers to safe
dietary supplements is necessary in order to promote
wellness.”[8] The DSHEA’s new class of products includes
vitamins, minerals, herbs, botanicals, amino acids, and
“dietary substance[s] for use by man to supplement the diet
by increasing the total dietary intake.”[9] This definition includes such products as fish oil,
ginseng, and the aforementioned ephedra and St. John’s
Wort.[10]

The DSHEA not only created a new class of products
but devised a new regulation scheme which the FDA must follow. In
contrast to new drugs and new food ingredients, supplements are not
subject to premarket approval.[11] Manufacturers can introduce products to the market
without testing them for safety or effectiveness. Further, based
upon Congressional findings, the assumption must be that the herbal
products are safe for the public. The FDA, rather than
manufacturers in the case of new food ingredients or drugs,
maintains the burden of proof for safety examinations.[12] The FDA may force dietary supplements off the
market only in cases where the products pose an “imminent
hazard to the public health and safety.”[13] The lag between market introduction and FDA action
allows potentially harmful products to be in consumers’ hands
for extended periods of time.

The FDA maintains oversight over not only a
product’s ingredients but also its labeling. The DSHEA
provides the FDA with such authority over dietary supplements and
sets out specific labeling standards for these products. Dietary
supplements may only make statements which claim “a benefit
related to a classical nutrient deficiency disease and discloses
the prevalence of such disease in the United States”,
describe “the role of a nutrient or dietary ingredient
intended to affect the structure or function in humans,”
characterize “the documented mechanism by which a nutrient or
dietary ingredient acts to maintain such structure or
function,” or describe “general well-being from
consumption of a nutrient or dietary ingredient.”[14] Therefore, manufacturers must limit their
statements to either nutritional deficiency, structure-function, or
well-being claims. However, any statement must also include a
prominently displayed disclaimer that the product is not evaluated
by the FDA nor “is not intended to diagnose, treat, cure, or
prevent any disease.”[15] If a claim is made that the dietary supplement
does intend to diagnose, treat, cure or prevent a disease,
then the manufacturer must notify the FDA of such a statement
within thirty days after first marketing the product.[16] Finally, and perhaps most importantly, any
statement made by the manufacturer on the product must be truthful
and not misleading.[17]

One further measure of power provided by the DSHEA
is the regulation of new ingredients. A new ingredient in a dietary
supplement is considered “adulterated” (and so may not
remain on the market) unless the “dietary supplement contains
only dietary ingredients which have been present in the food supply
as an article used for food in a form in which the food has not
been chemically altered” or “[t]here is a history of
use or other evidence of safety establishing that the dietary
ingredient when used under the conditions recommended or suggested
in the labeling of the dietary supplement will reasonably be
expected to be safe” and the manufacturer submits proof of
such reasonable expectation of safety to the FDA.[18] The DSHEA therefore allows a “grandfather
exemption” to any drugs which have already been on the
market. Even if a manufacturer creates a new use or dosage for that
ingredient, if it has already been in use and there is a reasonable
expectation of safety, then the DSHEA allows it to be introduced
for public sale.

II. Federal Trade Commission

Although the DSHEA institutes several regulatory
provisions for dietary supplements, including FDA oversight for
product labeling, it does not address product advertisements. The
Federal Trade Commission possesses authority over the advertising
of food, drugs, and herbal supplements. The Federal Trade
Commission Act prohibits “unfair or deceptive acts or
practices” and “any false advertisement” of food
products that is “misleading in a material
respect.”[19] Further, the FTC’s publication,
“Dietary Supplements: An Advertising Guide for
Industry,” adds an additional requirement that an advertiser
possess “adequate substantiation for all objective product
claims (before the advertisement is disseminated)”.[20]

In determining whether an advertisement fails to be
truthful or nonmisleading, the FTC analyzes the statements based on
both explicit and implicit claims.[21] Such an examination includes interpretations of
the claims based on the contexts of the advertisements and a
consideration of both what is explicitly stated and what
information is not included. In order to ensure that
statements are not misleading, the FTC has advised manufacturers to
“use clear language, avoid small type, place qualifying
information close to the claim, and avoid making inconsistent
statements or including distracting elements that undercut the
disclosure.”[22]

The addition of a requirement of substantiation for
dietary supplement advertisements imposes a duty on advertisers to
possess “competent and reliable scientific evidence” to
support each and every claim.[23] While the proper level of substantiation is
determined on a case-by-case basis, it is based upon the
FTC’s determination of the amount of substantiation normally
relied upon by researchers in the particular, and similar, fields
of study.[24] Such factors considered by the FTC include
“tests, analyses, research, studies, or other evidence based
on the expertise of professionals in the relevant area, that have
been conducted and evaluated in an objective manner by persons
qualified to do so, using procedures generally accepted in the
profession to yield accurate and reliable results."[25] Customer testimonials are generally not enough to
constitute support for a specific product claim.[26] While it is unclear whether a manufacturer must be
conduct studies to prove that its specific product is effective and
supports any advertised claims, rather than relying on established
studies of similar products, it appears that the FTC is leaning
towards imposing such a requirement.[27] Therefore, although a product may be nearly
identical to a competitor’s and that competitor has published
efficacy studies, reliance on that competitor’s research may
not be enough for a product to satisfy an FTC claim for lack of
substantiation.

The FTC also reviews customer testimonials in
determining whether the advertisement is both truthful and
non-misleading. Not only are such testimonials insufficient to
substantiate a claim made by the advertiser, a “clear and
conspicuous disclaimer” must appear on the
advertisement.[28] Further, the “advertiser should either state
what the generally expected results would be or indicate that the
consumer should not expect to experience the attested results.
Vague disclaimers like ‘results may vary’ are likely to
be insufficient.”[29] A disclaimer must provide information such as
whether the results promoted by the testimonial are similar to
results expected to be experienced by other users and, if not, what
a consumer should expect to gain (or lose) from consuming the
product.

Finally, while the two-part DSHEA disclaimer, "This
statement has not been evaluated by the Food and Drug
Administration. This product is not intended to diagnose, treat,
cure, or prevent any disease," applies only to product labeling and
not to advertising, the FTC has promoted its use when statements
made by the advertiser may be misleading to consumers.[30] If the advertisement leads consumers to believe
that the FDA has conducted studies on the safety or efficacy of the
product or somehow approved its use, the advertiser must use the
two-part disclaimer.[31] However, mere use of the disclaimer does not
provide a substitute for the claim substantiation and truthfulness
requirements of the FTC.[32]

ANALYSIS OF TRIMSPA

TrimSpa X32 is one of the newer and more heavily
advertised herbal weight loss products on the market today. The
manufacturer of TrimSpa X32 has launched an intense promotional
campaign with Anna Nicole Smith as celebrity endorser and is
currently promoting a “Million Dollar Makeover
Challenge” for its product. Further, the manufacturer of
TrimSpa X32 has produced numerous television advertisements for the
product, sponsored charity and promotional events, and maintains a
colorful website with information about the product, customer
testimonials, and, of course, a “Buy Now” feature.
However, one must question whether this product is safe and
effective and whether its advertising satisfies FTC requirements
for truthfulness and substantiation.

I. Two “Primary”
Ingredients

It appears from TrimSpa’s advertising and
information on its website that the TrimSpa X32 product relies on
two primary ingredients to produce the touted weight loss results:
Hoodia gordonii and glucasomine. While TrimSpa X32 contains
numerous other ingredients, such as gucomannan, green tea extract
and cocoa extract, consumers are led to believe that these
ingredients are supplementary to the more powerful effects of
Hoodia gordonii and glucasomine. Therefore, this paper will analyze
the two “primary” ingredients of TrimSpa X32.

a. Hoodia Gordonii

The most heavily touted ingredient in TrimSpa X32
is Hoodia gordonii. Although it is the third in terms of quantity,
it is first in terms of advertised benefits to the
consumer.[33] It is the first ingredient listed as part of the
TrimSpa X32 “formula”[34] and TrimSpa’s homepage touts the product
as “#1 in Hoodia gordonii.”[35] The manufacturer of TrimSpa X32 claims that the
primary ingredient in the product “to help achieve create a
sexier you” is Hoodia gordonii, which is “a natural
appetite suppressant, used for generations by South African
tribesmen to stave off hunger during long hunting
expeditions.”[36] While Hoodia gordonii is relatively new to the
Western World, it has, as stated by TrimSpa, been used for many
years by South African hunters.[37] However, such use may or may not translate to the
weight loss benefits sought by American consumers. Because the
DSHEA does not require premarket approval or safety and efficacy
testing prior to introduction to the market, one cannot be sure
that use of Hoodia gordonii via TrimSpa X32 is both safe and
effective. While small-scale studies have reported that both rats
and humans lost their appetites while taking Hoodia gordonii
without experiencing side effects,[38]no manufacturer or research body has
published a large-scale study as to the safety and efficacy of
Hoodia gordonii.[39] One major consumer products company, Unilever, has
announced a multi-stage research program to analyze the safety and
efficacy of Hoodia gordonii.[40] However, it will likely take a great amount of
time before the program is completed and consumers may look to a
formal study as to whether Hoodia gordonii actually works
appropriately as a safe weight loss supplement.

Yet, certain dangers of using Hoodia gordonii have
already been reported. Not only does Hoodia gordonii turn off the
one’s appetite, it also suppresses a user’s
thirst.[41] This lack of thirst could result in dehydration
and possibly death in users of Hoodia gordonii. Further, one doctor
reported that Hoodia gordonii “was not supposed to make you
lose weight; it was supposed to allow you to hunt successfully in a
difficult environment. It’s not unsafe, used the way it was
traditionally. But I don’t think we have any experience with
Hoodia and obesity.”[42] Nevertheless, because no study exists as to the
safety and efficacy of Hoodia gordonii, the FDA cannot use such
statements as “proof” that TrimSpa X32 must be removed
from the market. The FDA maintains the burden of proof as to
whether the product presents an imminent safety hazard to
consumers. It is doubtful that the potential dangers of dehydration
and the potential for harm in this new use of Hoodia gordonii would
be enough to reach that burden. Further, the description of Hoodia
gordonii as a “natural appetite suppressant” is neither
false nor misleading and so follows the applicable FDA regulations
under the DSHEA.

While Hoodia gordonii is “new” in terms
of its use in the United States, there is ample evidence as to its
safe and prolonged use in its native country. While the
manufacturer of TrimSpa X32 may be able to argue that such use
presents evidence as required by the grandfather clause of the
DSHEA, one may argue that the history of use was not under
the same conditions and dosage of TrimSpa X32. Even assuming that
the manufacturer of TrimSpa X32 followed the reporting guidelines
of the grandfather clause, it is possible that TrimSpa X32 fails on
the use and dosage requirement. Hoodia gordonii has been
used in other products, such as teas,[43] but there remains a question of how long such
products have been in the food supply and in what dosage.

b. Glucosamine

The second ingredient listed in the TrimSpa X32
“formula”, though sixth in terms of quantity, is
glucosamine.[44] TrimSpa’s website describes this ingredient
as “an ingredient, patented by TRIMSPA for weight loss, that
actually prolongs the amount of time glucose (or blood sugar) stays
within the bloodstream after eating. This delay means that any
extra insulin can be used directly by the muscles for energy,
instead of being transferred too quickly to the
‘warehouse,’ or fat cells.”[45] Studies as to the effectiveness of the use of
glucosamine for weight loss have been inconclusive. While some
studies have shown modest benefits, others have not shown any
benefits related to glucosamine use.[46] However, studies have shown that it does not
“appear harmful or to interact negatively with other
medications.”[47]

Rather than being used for weight loss, glucosamine
is primarily promoted for the treatment of arthritis,
“relieving osteoarthritis pain and slowing the degredation of
joint cartilage”.[48] Such use could fall within the DSHEA new
ingredient grandfather clause, but it may run afoul of the same
“conditions of use” and dosage issues as Hoodia
gordonii. But, this is not the only problem with glucosamine. The
FDA could cite the lack of studies which show significant benefits
to consumers seeking weight loss as evidence of false and
misleading statements. However, FDA retains the burden of proof and
the existence of studies showing modest benefits may be enough to
defeat such a claim. Finally, the use of glucosamine has been shown
to increase blood sugar levels in diabetics and increase the
body’s resistance to insulin. These effects present potential
health risks to consumers, especially if they are diabetic. While
the labeling on TrimSpa X32 does inform consumers with a
disclaimer, “Health Concerns: Do not take if you are a
diabetic,” the statement appears within a litany of other
disclaimers and may not be easily noted by diabetic
consumers.[49] If the FDA can find and report studies which
document such risks and prove that the existence of such risks
presents a significant health risk to consumers, then it is
possible for the FDA to pull TrimSpa X32 from the market.

II. Compliance with Additional DSHEA
Regulations

Although this paper has addressed whether or not
the FDA can force TrimSpa X32 off the market due to safety
concerns, there are several other regulations required by the
DSHEA. First, TrimSpa X32 must comply with the appropriate labeling
requirements. These requirements include labeling the product as a
dietary supplement and listing the name of each ingredient, the
quantity of each ingredient, the total quantity of ingredients in
the product, and the name and part of the plant each applicable
ingredient is derived.[50] TrimSpa X32’s label fulfills numerous facets
of the labeling requirements. All ingredients are identified, the
applicable plant name and part (for Hoodia gordonii) is listed, and
amount of each ingredient per serving is noted. Further, it lists
on the front of the bottle that it is a “dietary
supplement.” However, TrimSpa X32 does not list the total
quantity of dietary supplement ingredients. Therefore, it is not
technically in compliance with DSHEA and is subject to appropriate
sanctions by the FDA.

The DSHEA also requires that the labels are not
mislabeled as to their contents. If an ingredient is listed in an
“official compendium” but does not conform to the
specifications of that compendium or if that ingredient is not
listed in a compendium and either “fails to have the identity
and strength that the supplement is represented to have” or
“fails to meet the quality (including tablet or capsule
disintegration), purity, or compositional specifications, based on
validated assay or other appropriate methods, that the supplement
is represented to meet” then it will be deemed misbranded and
so be subject to sanctions by the FDA.[51] The DSHEA recognizes three such compendiums:
The official United States Pharmacopoeia, official Homoeopathic
Pharmacopoeia of the United States, official National Formulary,
and any supplement to these compendiums.[52] It is outside the scope of this paper to determine
whether all of TrimSpa X32’s ingredients are in compliance
with the labeling requirements (the author would need many more
months to undertake a determination as to whether each bottle of
TrimSpa X32 contains the ingredients in the type and quantity
listed on the label). However, class action lawsuits have been
filed in New York and California which allege that the manufacturer
of TrimSpa EF (“EF” is an acronym for “ephedra
free”) misrepresented the ingredients of the product and that
the product does not actually contain Hoodia gordonii.[53] While TrimSpa EF is a separate product, the
description of the product, and its endorsement by Anna Nicole
Smith is quite similar to that of TrimSpa X32. Therefore, it is
likely that TrimSpa X32 may face similar allegations of misleading
and fraudulent labeling in violation of the DSHEA.

An additional labeling requirement is that the
product must include the FDA two-part evaluation disclaimer.
TrimSpa X32 does include such a disclaimer and therefore is in
compliance with this obligation.

Finally, the DSHEA requires that the manufacturer
complies with good manufacturing practice. However, I am unable to
research whether TrimSpa X32 does or does not comply with this
particular requirement.

III. Duty-to-Warn Litigation

One must assume, even if based solely on a
doctor’s admonition in the LA Times , that the
manufacturer of TrimSpa X32 is aware of Hoodia gordonii’s
effect on thirst. Further, studies have shown that glucosamine may
affect insulin resistance and so have dire consequences for
diabetics.[54] If this is the case, then it is possible for a
user to allege that the manufacturer is liable in a failure-to-warn
claim. If a user does die of dehydration due to his or her use of
TrimSpa X32 or a diabetic is severely injured or killed due to the
effects of glucosamine, it is conceivable to allege that the
manufacturer is liable for the consumers’ deaths. In order to
prevail on such a claim, a plaintiff must successfully argue that
the manufacturer failed to adequately warn the consumer of a
product’s risks and that failure to warn was the proximate
cause of the plaintiff’s injury.[55] It appears that there have been few
duty-to-warn cases involving dietary supplements. Three cases were
filed involving Metabolife’s weight loss supplement product
(which contained ephedra). However, the plaintiffs failed in all
three cases.[56] Nevertheless, the failure of those cases does not
fortell the failure of claims in the future and it is conceivable
for a duty-to-warn case to succeed against the manufacturer of a
dietary supplement.

IV. Advertising

TrimSpa’s primary marketing conduits are
television commercials and websites. In both mediums, TrimSpa
promotes the X32 product through customer testimonials and
celebrity endorsements. Further, the TrimSpa website provides a
“consultation” service which helps consumers to choose
which product best suits their lifestyle and weight-loss goals.

It is not within the resources of this paper to
determine whether TrimSpa X32 fully complies with the FTC’s
requirement of substantiation for the product as a whole, because
the author does not have access to TrimSpa’s studies, if any,
of the numerous ingredients in TrimSpa X32 touted to aid the
consumer in losing weight. However, it is possible to question
certain aspects of TrimSpa X32’s primary (in terms of its
prominence in TrimSpa advertising) ingredients. The FTC has already
filed lawsuits against weight loss products, including Slim Down
Solution, which contain glucosamine.[57] However, the advertisements for these products
claimed to allow users to lose weight without changing their diet
or lifestyle. In contrast, the website and television
advertisements for TrimSpa X32 repeatedly encourage users to both
reduce food intake and increase exercise in order to achieve
maximum benefits. Therefore, it appears that TrimSpa X32 does
comply with the truthfulness and nonmisleading advertising
requirements of the FTC in this respect. However, in the orders
based on the its lawsuits against the weight loss products, the FTC
prohibited defendants “from claiming, without competent and
reliable scientific proof, that...D-glucosamine cause any weight
loss at all.”[58] These orders signal that TrimSpa X32’s use
of glucosamine may run afoul of the FTC’s substantiation
requirement unless they can provide the existence of studies which
are heretofore unknown to the FTC or manufacturers in the herbal
weight loss supplement industry.

Further, it is doubtful that the manufacturers of
TrimSpa or any similar weight loss product have conducted the
studies necessary to comply with the FTC substantiation requirement
for claims of the efficacy of Hoodia gordonii. As discussed above,
there is a dearth of information about this ingredient aside from
testimonials of users and small-scale unscientific studies.. Yet,
the advertising for TrimSpa X32 is able to bypass the need to
comply with the substantiation requirement because the
advertisements do not provide claims as to the benefits or efficacy
of Hoodia gordonii. On its website, the claims for Hoodia gordonii
are simply that the ingredient “is a natural appetite
suppressant, used for generations by South African tribesmen to
stave off hunger during long hunting expeditions.”[59] Such a simple claim is easily substantiated, as
that information has become public knowledge through a news segment
on the television show, “60 Minutes.”[60] Because the advertising does not specify benefits
of the ingredients, there is no necessity for substantiation.

MTV reality star Anna Nicole Smith provides a
testimonial in television commercials for TrimSpa X32, claiming
that the use of TrimSpa X32 helped her to lose several pounds and
become a “starlet” once again. Numerous customers tout
the great benefits achieved through the use of TrimSpa X32 on the
product’s website, claiming losses of up to 130
pounds.[61] At first glance, a skeptic may conclude that the
advertisements are blatantly misleading, presenting exceptions
rather than examples of average weight loss results. However, based
upon a strict reading of the FTC guidelines for dietary supplement
advertising, the manufacturer of TrimSpa X32 appears to be both
“truthful” and “nonmisleading.” The DSHEA
two-part disclaimer appears both in the television commercials and
at the bottom of the TrimSpa X32 website. Further, on each page of
the website, there is a lengthy disclaimer which includes the DSHEA
disclaimer and a statement that “[t]hese results are not
typical. X32 may not work for everyone. Average weight loss
achieved after 8 weeks using X32 with a reduced calorie diet and
exercise was between .6 to .8 pounds per week based on the interim
results of an ongoing clinical study.”[62] Further, it adds,“Consult physician before
using. Read the label and follow directions. Do not use if pregnant
or nursing. If you are allergic to shellfish, consult your doctor
before taking glucosamine. Models have been compensated for photos
and testimonials paid for commercial appearance.”[63] This lengthy disclaimer paragraph appears to
alleviate any questions of misleading claims or statements made in
the advertisements. Although the disclaimer is in smaller print
than the rest of the page, the information is sufficiently legible
and available to anyone reviewing the website.

While the testimonial section of the TrimSpa
website and on the television commercials consumes a significant
percentage of the advertising, the manufacturer of TrimSpa X32 does
note directly in the testimonials that reduced food intake and
increased exercise were a part of the consumer’s weight loss
program. For example, one testimonial proclaims, “I found
myself absolutely overcome with appreciation to TRIMSPA X32 and
everyday found increased determination to keep going. I had the
energy to eat right and make all the necessary changes to live
healthier.”[64] The statements that diet and other changes
contributed to the weight loss combined with the disclaimer which
included expected weight loss by consumers expressly comply with
the FTC’s guidelines for customer testimonials.

The consultation section, displayed prominently in
several different sections of the TrimSpa website, contains
numerous disclaimers and recommendations that the consumer see a
doctor and practice a healthy lifestyle.[65] This information appears to constitute truthful
and nonmisleading information as to the effectiveness of the
product and also serves as a disclaimer as to sole use of this
product for significant weight loss results. Not only does the
consultation section comply with FTC requirements but it serves as
an aid to the weight loss claims appearing elsewhere on the website
in ensuring that consumers are not mislead by the efficacy claims
made for the product.

CONCLUSION

While TrimSpa X32 has hit the consumer market with
a big splash of advertising, a million dollar giveaway and a
celebrity endorsement, there remains a question of whether it
should remain on the market. Under the DSHEA, it may continue to be
on the market until the FDA provides substantiation as to its
imminent danger to consumers. Until that time, TrimSpa X32 may
legally be sold throughout the country. The product complies with
all applicable FDA and FTC regulations and there currently appears
to have no reason to force TrimSpa X32 from the store shelves.
However, there remain significant questions as to the safety of the
product. Its primarily touted ingredient, Hoodia gordonii, is
relatively new to the Western World and there is little information
about both its short-term and long-term effects on the body. While
it may be safe for South African hunters, it is not necessarily
safe to dieting Americans. There is an undisclosed risk for
dehydration and perhaps other risks which are not presently known.
Nevertheless, until the FDA can assume its burden of proof, there
is nothing that regulators can do to pull the product out of the
hands of consumers.

[1]See Rob Stein, Fidgeting Helps Separate the
Lean From the Obese , Study Finds , The Washington Post,
Jan. 28, 2005, at A2, reporting that two-thirds of Americans are
overweight; See also , National Center for Chronic Disease
Prevention and Health Promotion, U.S. Obesity Trends 1985-2003.

[19] Robert G. Pinco and Todd H. Halpern, Guidelines
for the Promotion of Dietary Supplements: Examining Government
Regulation Five Years After Enactment of the Dietary Supplement
Health and Education Act of 1994 , 54 Food Drug L.J. 567, 580
(1999).